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Table 6 Most frequent (serious) adverse events

From: Electrocardiographic assessments and cardiac events after fingolimod first dose – a comprehensive monitoring study

  Fingolimod 0.5 mg N = 3951
Number of patients, n (%) Number of events, n
Summary of adverse events
 Any adverse event 1350 (34.17) 2207
 Any serious adverse event 117 (2.96) 152
 Any adverse event leading to discontinuation of study drug 38 (0.96) 69
Common adverse events (>1% in SOC/PT)
 Nervous system disorders 403 (10.20) 464
  Headache 199 (5.04) 205
  Dizziness 72 (1.82) 73
  MS relapse 58 (1.47) 59
 General disorders and administration site conditions 240 (6.07) 265
  Fatigue 135 (3.42) 138
 Cardiac disorders 231 (5.85) 263
  AV block first degree 69 (1.75) 70
  AV block second degree 65 (1.65) 67
  Bradycardia 45 (1.14) 45
 Gastrointestinal disorders 217 (5.49) 246
  Nausea 91 (2.30) 92
  Diarrhoea 52 (1.32) 52
 Infections and infestations 170 (4.30) 178
  Nasopharyngitis 78 (1.97) 78
 Investigations 130 (3.29) 150
 Blood and lymphatic disorders 115 (2.91) 140
  Lymphopenia 73 (1.85) 74
 Musculoskeletal and connective tissue disorders 94 (2.38) 102
 Skin and subcutaneous tissue disorders 66 (1.67) 69
 Psychiatric disorders 61 (1.54) 63
 Vascular disorders 60 (1.52) 61
 Respiratory, thoracic and mediastinal disorders 59 (1.49) 60
 Ear and labyrinth disorders 47 (1.19) 49
Common serious adverse events (>0.1% in SOC/PT)
 Cardiac disorders 52 (1.32) 65
  AV block second-degree 31 (0.78) 33
  Bradycardia 15 (0.38) 15
  AV block 5 (0.13) 5
 Nervous system disorders 33 (0.84) 36
  MS relapse 18 (0.46) 19
 General disorders and administration site conditions 7 (0.18) 7
 Infections and infestations 7 (0.18) 7
 Gastrointestinal disorders 6 (0.15) 8
 Vascular disorders 6 (0.15) 6
Symptoms that might have resulted from cardiac events (at Visit 2)
 Fatigue 68 (1.72)  
 Dizziness 26 (0.66)  
 Chest discomfort 8 (0.20)  
 Vertigo 7 (0.18)  
 Palpitations 7 (0.18)  
 Dyspnea 5 (0.13)  
 Angina pectoris 3 (0.08)  
 Blurred vision 2 (0.05)  
 Syncope 1 (0.03)  
 Exertional dyspnoe 1 (0.03)  
  1. PT preferred term, SOC system organ class